RAC-GS PDF Exam Material 2022 Realistic RAC-GS Dumps Questions
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NEW QUESTION 54
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?
- A. Placebo-controlled
- B. Cross-over
- C. Active-controlled
- D. Dose-ranging
Answer: B
NEW QUESTION 55
As a member of the product launch review committee, a regulatory affairs professional discovers a major
issue with the labeling of a product prior to production. In addition to informing the committee, which is the
BEST approach to address the issue?
- A. Inform the regulatory authorities.
- B. Delay the start of product production.
- C. Correct the label text.
- D. Abort the product launch.
Answer: A
NEW QUESTION 56
A company establishes a new medical device indication for its consumer disposable products. The
regulatory affairs professional is asked to give a 30-minute training session on these products to sales
representatives. Which of the following subjects is the MOST important to discuss?
- A. Labeling
- B. Safety-related reporting
- C. Risk management process
- D. Regulatory application summary
Answer: A
NEW QUESTION 57
Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?
- A. The device incorporates well-established technology that is already present in the market.
- B. The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change. - C. Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer. - D. The manufacturer's experience level with the type of IVD medical device is limited.
Answer: D
NEW QUESTION 58
Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A
regulatory authority requires that all labeling for Company Y's products be converted to Company X within
three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet
this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the
situation?
- A. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority
requirement and assign responsibilities. - B. Submit as many labeling conversion applications as possible within the time frame and request an
extension for the remaining ones. - C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
from the regulatory authority. - D. Request additional resources from senior management in order to complete the labeling conversion
within the time frame given by the regulatory authority.
Answer: C
NEW QUESTION 59
A company's product was approved by a regulatory authority with the condition that further studies must
be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the
LEAST effective way to achieve this goal?
- A. Label the product for use in appropriate populations.
- B. Promote off-label use to a carefully selected patient population.
- C. Delay product launch until required studies are completed.
- D. Educate patients and healthcare providers on how to use the product
Answer: B
NEW QUESTION 60
Company X is planning to acquire the rights for a product marketed by Company Y. As part of due
diligence, what is the MOST important information the Company X regulatory affairs professional should
ask senior management to request from Company Y?
- A. Intellectual properly
- B. Marketing materials
- C. Clinical trial data
- D. Safety issues
Answer: D
NEW QUESTION 61
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be sold or offered for sale in domestic commerce.
- B. The product must not be in conflict with the laws of the country to which it is intended for export.
- C. The product must not be labeled on the outside of the shipping package that it is intended for export.
- D. The product must not be in accord with the specifications of the foreign purchaser.
Answer: B
NEW QUESTION 62
In preparation for the development of a new line of products, a regulatory affairs professional is asked to
prepare a short presentation for senior management. Which of the following topics is MOST important to
cover?
- A. Potential clinical sites for the Phase III clinical trial
- B. Capacity of the manufacturing facilities to fully produce the new product
- C. Previous actions taken by regulatory authorities on similar products
- D. Regulatory requirements for labeling and packaging
Answer: C
NEW QUESTION 63
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. ISO 13485
- C. ICH guidelines
- D. IEC 60601
Answer: B
NEW QUESTION 64
At a recent scientific meeting, Company Y had two booths:
. At one booth, Company Y provided brochures on a completed Phase II study.
. In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed
products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting
that Company Y stop this practice in the future and demanding a formal response to the letter. How
should the regulatory affairs professional at Company Y BEST respond?
- A. Inform the local regulatory authority of the letter and discuss how to respond.
- B. Inform the legal department of the letter and discuss how to respond.
- C. Acknowledge receipt of the letter in a written response but do nothing further.
- D. Inform Company X that it has no right to send such a letter and do nothing further.
Answer: B
NEW QUESTION 65
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Summarize regulatory documents and history and provide the information to the management team.
- B. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - C. Obtain competitor research and provide the information to the management team.
- D. Obtain regulatory documents and history and provide the information to R&D.
Answer: A
NEW QUESTION 66
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. As many as required by international standards
- B. All senior management from the main office
- C. As many as government attendees
- D. The minimum number of attendees necessary to address the issues
Answer: D
NEW QUESTION 67
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Request that doctors stop using the product for the off-label indication.
- B. Communicate with the sales department to stop using the promotional materials.
- C. Allow doctors to use the product for the off-label indication.
- D. Contact the marketing department to recall the product.
Answer: B
NEW QUESTION 68
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left
alone in the records room. The records room contains information on all products produced by the
contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor accompanied access to the room to retrieve the records.
- B. Allow the auditor access to the room and records due to the current audit.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Deny the auditor access to the room and retrieve only the requested records.
Answer: A
NEW QUESTION 69
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage
should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Plasma fractionation
- C. Individual plasma donation
- D. Product distribution
Answer: D
NEW QUESTION 70
The safety database for an anti-hypertensive drug consists of the following:
. 461 patients exposed for three months
. 343 patients exposed for six months
. 112 patients exposed for nine months
. 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 200 patients for nine months
- B. 3.000 total patient exposures
- C. 100 patients for 12 months
- D. 500 patients for three months
Answer: C
NEW QUESTION 71
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?
- A. The ISO national member body
- B. The ISO technical committee in charge of the area
- C. The ISO Secretariat
- D. The country's regulatory authority
Answer: A
NEW QUESTION 72
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug
produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly
different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Ask that the regulatory authority provide the actual product subject to the complaint.
- B. Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release. - C. Ask that the regulatory authority provide the batch number printed on the packaging of the affected
product. - D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product.
Answer: C
NEW QUESTION 73
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Obtain a copy of the proposed regulation and analyze the impact.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Arrange for additional testing of the product at the testing facility.
Answer: A
NEW QUESTION 74
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?
- A. Local reimbursement requirements
- B. Training program for sales people
- C. Service operation procedures .
- D. Written procedure for product traceability
Answer: B
NEW QUESTION 75
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk reduction
- C. Risk evaluation
- D. Risk analysis
Answer: A
NEW QUESTION 76
In order to develop a global drug product, what is the MOST important environmental characteristic to
consider in the country of intended use?
- A. Product stability
- B. Product requirements
- C. Product formulation
- D. Product registration
Answer: A
NEW QUESTION 77
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 78
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on
the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 79
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